MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Model Number SGC0701

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Perforation (2001)

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional two devices referenced are filed under separate medwatch report numbers.

Event Description

This is filed to report atrial perforation.It was reported this was a mitraclip procedure performed to treat functional mitral regurgitation (mr) with a grade of 4.It was noted the patient had a floppy septum and imaging was very challenging.The steerable guide catheter (sgc) and an ntw clip delivery system (cds) were inserted.However, due to the floppy septum, the sgc was difficult position.Also, due to the poor imaging, it was difficult to visualize the sgc and cds.Although imaging was very poor, the physician decided to attempt to steer down into the left ventricle (lv).It was noted a lot of tension was put on the device due an excessive amount of steering.When attempting to release some of that tension, it was observed the clip moved in an unintended direction.The cds was attempted to be pulled back into the left atrium (la), but the clip became caught in the chordae and the commissure, resulting in a clinically significant delay in the procedure.Troubleshooting was performed and the clip was able to be retracted into the la.However, a chordal rupture occurred.The physician decided to remove the cds and replace it with another ntw.The clip was deployed on the mitral valve without issues.To further reduce mr, an nt clip was inserted and attempted to be placed laterally of the first clip.However, while grasping, the implanted clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).The nt clip was then repositioned to stabilize the slda.Mr was reduced to a grade of 2.Once the cds and sgc were removed, a left to right shunt was observed.However, no treatment was performed.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation determined the reported difficult positioning was due to patient morphology/pathology and poor image resolution was due to procedural condition.In addition, the reported perforation appears to be due to procedural condition.Perforation is listed in the instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12953148
• MDR Text Key: 281858670
• Report Number: 2024168-2021-11182
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10520R215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM.
• Patient Outcome(s): Other
• Patient Sex: Female